Manufacturers of Class I (sterile/measuring), IIa, IIb and III devices must obtain certification against the CE marking directive, 93/42/EEC, from a Notified Body before using the CE mark and placing products on the market.

Our global network of local offices ensures that wherever your company or manufacturing is based, 93/42/EEC certification can be achieved effectively and efficiently.

The certification options under this directive include Annex II, V and VI comprise site audits and assessment of technical documentation. Our site audits will usually assess compliance with both ISO 13485:2003 and directive 93/42/EEC.

United Kingdom Accreditation Service (UKAS) accreditation and close links with European Commission and Competent Authorities make us a natural partner to meeting your CE certification requirements. Partnering with SGS gives you access to expert knowledge, a global network of auditors and the opportunity to combine CE Marking with our wide range of other regulatory certification in one audit.